Birth Defects and Decreased IQ

Inform pregnant women and women
of childbearing potential that use of valproate during pregnancy increases the
risk of birth defects and decreased IQ in children who were exposed. Advise
women to use effective contraception while using valproate. When appropriate,
counsel these patients about alternative therapeutic options. This is
particularly important when valproate use is considered for a condition not
usually associated with permanent injury or death [see WARNINGS AND
PRECAUTIONS and Use In Specific Populations].

Advise women of childbearing
potential to discuss pregnancy planning with their doctor and to contact their
doctor immediately if they think they are pregnant.

Hyperammonemia

Inform patients of the signs
and symptoms associated with hyperammonemic encephalopathy and be told to
inform the prescriber if any of these symptoms occur [see WARNINGS AND
PRECAUTIONS].

CNS Depression

Since valproate products may
produce CNS depression, especially when combined with another CNS depressant
(e.g., alcohol), advise patients not to engage in hazardous activities, such as
driving an automobile or operating dangerous machinery, until it is known that
they do not become drowsy from the drug.

Multiorgan Hypersensitivity Reactions

Instruct patients that a fever associated with other
organ system involvement (rash, lymphadenopathy, etc.) may be drug-related and
should be reported to the physician immediately [see WARNINGS AND PRECAUTIONS].

Last reviewed on RxList: 3/9/2015
This monograph has been modified to include the generic and brand name in many instances.